Revenue and Financial Performance - Revenue for the three and six months ended June 30, 2024, was $4,000 and $33,000, respectively, compared to $373,000 for both periods in 2023, indicating a significant decline in revenue [113][138]. - The company reported a net cash used in operating activities of $3.6 million for the six months ended June 30, 2024, a decrease of $4.6 million from $8.2 million in the same period of 2023 [127]. - As of June 30, 2024, cash and cash equivalents were $6.0 million, down from $10.2 million in 2023, raising concerns about the company's ability to continue as a going concern [125][124]. - The accumulated deficit as of June 30, 2024, was $434.5 million, reflecting the company's ongoing financial challenges [125]. - Total income tax benefit decreased by approximately $0.1 million, from $1.9 million for the six months ended June 30, 2023 to $1.8 million for the six months ended June 30, 2024 [155]. - Total other income decreased by $60,000 from $90,000 for the six months ended June 30, 2023 to $30,000 for the six months ended June 30, 2024 [149]. Research and Development Activities - The Phase 1/2 study of fadraciclib involved 47 heavily pretreated patients, with two partial responses reported in patients with T-cell lymphoma [115][119]. - The Phase 2 proof of concept part of the fadraciclib study is currently enrolling patients with relevant biomarkers, including CDKN2A and/or CDKN2B mutations [120]. - The Phase 1/2 study of plogosertib has treated 15 patients with no dose-limiting toxicities observed, and stable disease has been noted in pretreated patients [122][123]. - Total research and development expenses decreased by $5.6 million from $10.4 million for the six months ended June 30, 2023 to $4.8 million for the six months ended June 30, 2024, representing a 54% decline [144]. - Research and development expenses for the transcriptional regulation program decreased by $3.9 million, primarily due to decreases in manufacturing and non-clinical expenditure [144]. - Overall research and development expenses for the year ended December 31, 2024 are anticipated to decrease compared to 2023, focusing primarily on clinical trial costs [145]. - Research and development expenses represented 60% of operating expenses for the six months ended June 30, 2024, down from 76% in 2023 [143]. - The amount of research and development tax credits is dependent on eligible expenses incurred and may be restricted by future caps introduced by HMRC [156]. Administrative and Future Outlook - General and administrative expenses remained relatively consistent at $3.2 million for the six months ended June 30, 2024 and 2023, representing 40% of operating expenses in 2024 compared to 24% in 2023 [146][147]. - The company expects general and administrative expenditures for the year ended December 31, 2024 to be lower than in 2023 due to cost-cutting efforts [148]. - Future funding requirements will depend on various factors, including the progress of clinical trials and the ability to secure additional financing [132][136]. - The company plans to explore in-licensing and acquisition opportunities to enhance its drug development strategy [131]. - The company expects to fulfill its obligations under a clinical manufacturing agreement by the third quarter of 2024 [139]. Foreign Exchange and Other Financial Metrics - Foreign exchange gains increased by $165,000, from a loss of $161,000 for the six months ended June 30, 2023, to a gain of $4,000 for the six months ended June 30, 2024 [152].

Financial Performance - The company reported revenue of $29,000 for the three months ended March 31, 2024, compared to no revenue for the same period in 2023[108]. - The company had cash and cash equivalents of $2.8 million as of March 31, 2024, down from $11.4 million in the same period of 2023[118]. - The total working capital as of March 31, 2024, was negative $3.5 million, compared to positive $11.6 million in 2023[118]. - The company has an accumulated deficit of $431.2 million as of March 31, 2024[120]. Research and Development Expenses - Research and development expenses totaled $2.8 million for the three months ended March 31, 2024, a decrease of 51% from $5.7 million in the same period of 2023[134]. - Research and development expenses decreased by $2.9 million from $5.7 million in Q1 2023 to $2.8 million in Q1 2024, primarily due to reductions in manufacturing and non-clinical expenditure[137]. - Research and development expenses for the year ended December 31, 2024 are anticipated to decrease compared to 2023 as the company focuses on Phase 1/2 programs[138]. Specific Program Expenses - The transcriptional regulation program (fadraciclib) incurred $1.75 million in expenses, down 57% from $4.09 million in the prior year[134]. - The epigenetic/anti-mitotic program (plogosertib) expenses were $963,000, a decrease of 29% from $1.35 million in the same period of 2023[134]. Operating Activities - The company used net cash of $0.6 million for operating activities in the three months ended March 31, 2024, a significant decrease from $6.9 million in the same period of 2023[121]. General and Administrative Expenses - General and administrative expenses decreased by $0.1 million from $1.645 million in Q1 2023 to $1.582 million in Q1 2024, representing 36% of operating expenses in Q1 2024 compared to 22% in Q1 2023[139]. - General and administrative expenditures for the year ended December 31, 2024 are expected to remain relatively flat compared to 2023[140]. Other Income and Tax Benefits - Total other income decreased by $0.1 million from $0.2 million in Q1 2023 to $0.1 million in Q1 2024, with royalties from an Asset Purchase Agreement contributing $52,000 in Q1 2024[141][142]. - Foreign exchange gains improved from a loss of $87,000 in Q1 2023 to a gain of $1,000 in Q1 2024, reflecting an increase of $88,000[143]. - The total income tax benefit increased by $34,000 from $1.320 million in Q1 2023 to $1.354 million in Q1 2024, remaining flat at approximately $1.3 million for both periods[146]. - Other income (expense), net for the year ended December 31, 2024 will be influenced by foreign exchange rate changes and income from the Asset Purchase Agreement[144]. Future Plans and Expectations - The company plans to enroll patients in the Phase 2 proof-of-concept stage for fadraciclib, focusing on cohorts with relevant biomarkers[113]. - The ongoing Phase 1/2 study of plogosertib has treated 15 patients with no dose-limiting toxicities observed[116]. - The company expects to continue receiving UK research and development tax credits for the year ended December 31, 2024, dependent on eligible expenses incurred[147]. Accounting Policies - There have been no material changes to the company's critical accounting policies during the three months ended March 31, 2024[149].

Clinical Trials and Drug Development - The company has no products approved for sale and cannot guarantee that it will ever have marketable products [177]. - Clinical trials are expensive and time-consuming, with potential delays that may extend beyond available funding [169]. - The company has experienced delays in clinical trials, including a failed SEAMLESS Phase 3 study that did not reach its primary endpoint [172]. - The approval process for drug candidates is lengthy and unpredictable, often taking many years and requiring extensive data submission [184]. - The company relies on biomarkers for drug development, but these biomarkers are not scientifically validated, which may lead to inefficient resource allocation [181]. - Undesirable side effects from product candidates could delay or prevent marketing approval, affecting patient recruitment and trial completion [190]. - The company has limited experience in planning and conducting clinical trials necessary for marketing approvals [185]. - The inability to enroll sufficient subjects in clinical trials could result in significant delays and increased development costs [176]. - The company may face competition for patient enrollment from other clinical trials targeting the same indications [175]. - The company must conduct significant additional clinical trials before seeking regulatory approvals for its drug candidates, which are currently in early to mid-stages of testing [271]. Regulatory and Compliance Challenges - Regulatory authorities may approve drug candidates for fewer or more limited indications than requested, impacting commercial prospects [187]. - Regulatory approvals for product candidates could be delayed or denied due to issues with preclinical studies conducted before in-licensing [196]. - Even with regulatory approval, the company will be subject to ongoing regulatory requirements, including manufacturing and post-marketing obligations [197]. - The company must ensure compliance with regulatory requirements in both domestic and international markets to avoid delays in product introduction [205]. - Regulatory changes and additional government regulations could hinder the approval process for product candidates [203]. - The company is subject to various federal and state healthcare fraud and abuse laws, which could result in substantial penalties if compliance is not achieved [253]. - Non-compliance with privacy and data protection laws could lead to liability, reputational harm, and increased compliance costs, particularly with the evolving regulatory landscape in the EU and UK [256]. - The General Data Protection Regulation (GDPR) imposes strict requirements on the processing of personal data, with potential fines of up to €20 million or 4% of annual global revenues for non-compliance [259]. - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose significant obligations on the handling of personal information, with penalties up to $250,000 for violations [264]. - The interplay of federal and state laws creates complex compliance issues that could expose the company to additional expenses and liabilities [265]. - The company’s operations involve the use of hazardous materials, which are subject to strict regulations and could lead to costly compliance issues and potential lawsuits [267]. - The company may incur significant costs related to compliance with evolving privacy and data security laws, which could negatively impact business operations [266]. - Future government enforcement actions could result in significant penalties and adverse publicity, affecting the company's business [266]. Financial Condition and Funding - As of December 31, 2023, the company's accumulated deficit was $428.3 million, with a net loss of $22.5 million for the year [271]. - The company has $3.4 million in cash and cash equivalents as of December 31, 2023, raising substantial doubt about its ability to continue as a going concern for the next year [273]. - The company has incurred operating losses every year since 1996, primarily due to research and development costs, and may never achieve profitability [271]. - The company plans to fund its operations through public equity, private placements, and other financing methods, but may face dilution of existing stockholders' interests [272]. - The company may need to raise substantial additional funding to support its research, development, and commercialization efforts [290]. - Funding constraints may delay the development of certain product candidates, impacting commercialization timelines [293]. - Economic disruptions and unstable market conditions could adversely affect the company's ability to secure necessary financing [276]. Market Competition and Acceptance - The company anticipates facing intense competition from other pharmaceutical and biotechnology companies with similar drug candidates [210]. - Future product candidates may encounter competition from generic drugs sooner than expected, impacting market share and revenue [211]. - Market acceptance of drug candidates will depend on factors such as safety, efficacy, pricing, and reimbursement policies from third-party payors [220][225]. - Failure to achieve market acceptance could significantly affect the company's ability to generate revenue and achieve profitability [222]. - The company faces challenges in determining the cost-effectiveness and reimbursement levels for its product candidates, which may affect competitive pricing [226]. - Legislative discussions at the federal level could require manufacturers to pay higher rebates in Medicare Part D, impacting reimbursement for products [227]. - The company is focusing its clinical development strategy on two ongoing hemato-oncology programs related to transcriptional regulation and mitosis control biology [293]. Intellectual Property and Legal Risks - Intellectual property rights are critical for commercial success, and inadequate enforcement could harm the company's competitive position [317]. - The company may face challenges in patent protection, as competitors can argue for the invalidity of patents or create non-infringing versions of drug candidates [319]. - Trade secrets are crucial for the company, but they are difficult to protect, and unauthorized disclosures could harm competitive positioning [320]. - The company may not obtain patent term extensions under the Hatch-Waxman Act, potentially shortening the exclusive marketing period and reducing revenue [323]. - The company could incur substantial costs from litigation related to patent rights, which may divert management's attention and resources [328]. - The company is subject to various patent-related risks, including potential infringement claims that could delay or prevent commercialization of drug candidates [326]. - The patent application process is complex and uncertain, with potential challenges that could negatively impact the company's patent position [333]. Operational and Management Challenges - The company may face difficulties in managing growth and expanding operations as it transitions from discovery and development to commercialization of drugs and devices [193]. - The company is highly dependent on skilled personnel for drug development and commercialization, with competition for talent likely to continue [229]. - Labor shortages and increased turnover rates may lead to higher operational costs, including overtime and wages [230]. - The company does not own manufacturing facilities and relies on third-party contract manufacturing organizations (CMOs) for drug supplies, which may lead to supply interruptions [307]. - Compliance with FDA manufacturing regulations requires significant resources, and failure to meet these could result in regulatory actions that adversely affect product development [311]. - Strategic alliances are crucial for drug development; failure to secure these could lead to increased expenditures or delays in drug candidate development [313][314]. - The company faces significant competition in forming strategic alliances, which may impact the scope and timeline of drug development programs [314]. Stock and Market Risks - The market price of the company's common and preferred stock may experience significant fluctuations due to various factors, including regulatory developments and announcements of new products [358]. - The company’s operating losses may fluctuate significantly on a quarterly basis, which could impact stock price and investor expectations [343]. - The existence of anti-takeover provisions in the company's charter documents may make acquisitions more difficult and entrench management [345]. - If securities analysts downgrade the company's stock or fail to publish reports, it could lead to a decline in stock price and trading volume [344]. - The company may face substantial costs and management distraction from potential litigation related to stock price fluctuations [360]. - The future sale of common and convertible preferred stock could negatively affect stock price and cause dilution for existing shareholders [361]. - The company’s ability to pay cash dividends on preferred stock is limited by Delaware law and its current financial condition [356]. - Engaging in short sales of the company's common stock may lead to a decline in its market price [367]. - A significant number of short sales can create downward pressure on the market price of the security [367]. - The exercise of outstanding warrants could increase the number of shares available in the market, potentially causing further declines in stock price [367]. - Short sellers may lock in profits by covering through the exercise of options or warrants [367]. - The company warns that further sales of common stock could undermine the value of its shares [367]. - Investors could experience a decline in the value of their investment due to short sales [367].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 | Title of each class | Trading Symbol(s) | Name of each excha ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specifi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 | Delaware | 91-1707622 | | --- | --- | | (State or Other Jurisdiction | (I.R.S. Employer | of Incorporation or Organization) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 00-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 91-1707622 (State or Other Jurisdiction of Incorp ...